PALO
ALTO, Calif., Nov. 14,
2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq:
KOD), today reported business highlights and financial results for
the quarter ended September 30,
2024.
"In the third quarter we hosted an Investor R&D Day in
New York," said Victor Perlroth, M.D., Chief Executive Officer
of Kodiak Sciences. "The Investor R&D Day webcast and
presentation provide a comprehensive and up-to-date overview of
where we stand today and where we are going – this is what I call
'Kodiak 2.0'. The video webcast includes scientific, clinical and
commercial perspectives from key retina opinion leaders Dr.
David Brown and Dr. Charles Wykoff. We encourage you to study these
materials which are available on the Investors & Media page of
our website."
"Key analysts, investors and retina specialists were in
attendance," continued Dr. Perlroth. "Together, we did a deep dive
into Kodiak's R&D and corporate activities. We presented new
clinical data supporting our science of durability, with tarcocimab
achieving an ocular half-life in patients of 20 days which is
3-times longer than faricimab and 2- to 3- times longer than
aflibercept. We also presented the rationale behind the enhanced
formulations of our ABC medicines, tarcocimab and KSI-501, which
are designed to deliver strong immediacy and Kodiak's
signature 6-month durability. We announced the new phase 3 GLOW2
study is enrolling patients in diabetic retinopathy and is designed
to repeat the successful GLOW1 study with all patients on 6-month
dosing. We announced the new phase 3 DAYBREAK study is enrolling
patients in wet AMD and investigating the two key unmet needs
of longer durability with tarcocimab and better efficacy with
KSI-501. Finally, we announced the new unconjugated bispecific
antibody KSI-101 clinical program is enrolling patients with
macular edema secondary to inflammation in our APEX study."
"We also put our three clinical programs into their commercial
context," continued Dr. Perlroth. "In the large retinal vascular
diseases anti-VEGF market, the opportunity is still open for a
therapy with both high efficacy and high durability. With
tarcocimab and KSI-501, we have the science of immediacy/efficacy
based on their enhanced formulations and the science of durability
based on their ABC platform designs."
"In the KSI-101 macular edema inflammation market, we note that
intraocular inflammation is the fourth leading cause of vision loss
in the developed world. One-third of patients with intraocular
inflammation develop macular edema, which is the leading cause of
vision loss among patients with intraocular inflammation. In
the United States, this population
of macular edema and inflammation is more than 100,000 patients,
and today these patients have no approved therapy other than
steroids. There is a commercial opportunity and high unmet need for
a powerful, safe local therapy, such as KSI-101 which is a
traditional (unconjugated) intravitreal biologic that targets
multiple underlying mechanisms of disease and which has the
potential to be disease-modifying. We believe macular edema
secondary to inflammation ("MESI") is an attractive indication for
drug development with its 16-week primary endpoint versus sham as
planned for our PEAK and PINNACLE phase 2b/3 studies," concluded Dr. Perlroth.
"To that end, in our new APEX cohorts, we are already seeing
meaningful clinical responses in sick patients with macular edema
secondary to inflammation," said Dr. Pablo
Velazquez-Martin, Chief Medical Officer of Kodiak Sciences.
"These emerging data, although early, are consistent with the
design and profile of our new KSI-101 investigational therapy with
its bispecific anti-inflammatory mechanism of action and local
intravitreal administration. We look forward to continuing to dose
additional patients and to presenting emerging APEX data in MESI
patients in the first and second quarters of 2025."
"In the third quarter, we continued the enrollment of subjects
across all three of our clinical programs. It is our objective to
complete enrollment for the Phase 3 GLOW2 and DAYBREAK studies of
tarcocimab and KSI-501 in the first half of 2025, so we and all
Kodiak stakeholders can have a clear line of sight to our 48-week
topline data readouts. If GLOW2 and DAYBREAK are successful, we
plan to file a single Biologics License Application ("BLA") for
three diseases (wet age-related macular degeneration, retinal vein
occlusion and diabetic retinopathy) with data from five successful
Phase 3 studies with tarcocimab."
"For KSI-101, in the second quarter of 2025, we hope to be in a
position to select the two dose levels to progress into the pivotal
program and to activate the twin PEAK and PINNACLE pivotal studies.
It is a time of strong execution, and we are pleased with the
growing enthusiasm and momentum from patients, retina specialists
and clinical practices who are key partners in our mission to
prevent and treat the leading causes of vision loss," concluded Dr.
Velazquez-Martin.
Recent Business Highlights
- Investor R&D Day: We hosted an Investor
R&D Day with financial analysts and institutional investors on
September 23, 2024, in New York City, with a webcast available for
virtual attendees. The event featured presentations and roundtable
discussions on Kodiak's science of durability, including (i)
first-time presentation of human ocular half-life data of
tarcocimab, (ii) science of the enhanced formulation for the
Antibody Biopolymer Conjugate ("ABC") Platform, including how the
enhanced formulations of tarcocimab and KSI-501 are designed to
provide strong immediacy while preserving their signature 6-month
durability profile, (iii) updates on our clinical programs
including rationale on how our pivotal Phase 3 studies GLOW2 and
DAYBREAK are designed to maximize probability of success, and (iv)
new progress on our preclinical pipeline including new glaucoma and
geographic atrophy programs built from our Antibody Biopolymer
Conjugate Drug ("ABCD") Platform.
Leading retina specialist key opinion leaders Dr. David Brown and Dr. Charles Wykoff joined us at the event as guest
speakers and shared their perspectives. The event was well-attended
by financial analysts and invited institutional investors.
- Tarcocimab Clinical Program: In the third
quarter of 2024 we continued enrollment for the ongoing Phase 3
GLOW2 study of tarcocimab in diabetic retinopathy ("DR").
GLOW2 is a prospective, randomized, double-masked, multi-center
pivotal superiority study designed to evaluate the efficacy and
safety of tarcocimab tedromer in treatment-naïve patients with DR.
Patients are randomized 1:1 to receive either sham injections or
tarcocimab via intravitreal injection at baseline, Week 4, Week 8,
Week 20 and Week 44. The primary endpoint is the proportion of eyes
improving ≥2 steps on Diabetic Retinopathy Severity Scale ("DRSS")
from baseline at Week 48. Additional outcome measures include the
proportion of eyes developing a sight threatening complication of
diabetic retinopathy and the proportion of eyes improving ≥3 steps
on DRSS from baseline at Week 48.
GLOW2 is the second Phase 3 study of tarcocimab in DR in which all
patients randomized to investigational therapy will receive
tarcocimab on extended, 6-month dosing. The GLOW2 study design
mirrors that of the successful GLOW1 Phase 3 study with the benefit
of an additional, third monthly loading dose (baseline, Week 4,
Week 8). If successful, GLOW2 could serve as one of the two
successful pivotal studies in one foundational indication, diabetic
retinopathy, to support the marketing authorization application for
tarcocimab.
In the third quarter of 2024, we continued site activations and
patient enrollment for the Phase 3 DAYBREAK study in wet
age-related macular degeneration ("AMD"). The DAYBREAK study
includes tarcocimab in a second investigational arm against active
comparator aflibercept and incorporates learnings from prior
pivotal trials of tarcocimab to maximize the probability of meeting
the primary endpoint of non-inferiority in visual acuity gains.
Patients randomized to tarcocimab will receive individualized
dosing every 4 to 24 weeks on an as needed basis following four
monthly loading doses. Patients randomized to aflibercept will be
dosed per its label. The individualized dosing of tarcocimab is
determined by a treat-to-dryness proactive approach using presence
of retinal fluid as a disease activity marker which (i) is the way
retina specialists actually treat patients in the real world, (ii)
results in a treatment every time it is needed, (iii) prevents
undertreatment, and (iv) enhances the probability of meeting the
primary endpoint. The objectives for tarcocimab in DAYBREAK are to
assess its 6-month durability potential, strengthen its competitive
position in wet AMD, and bolster the regulatory application package
for the program.
Both GLOW2 and DAYBREAK use tarcocimab's enhanced 50 mg/mL
formulation containing both conjugated and unconjugated antibody
that is intended to balance immediacy and durability.
- KSI-501 Clinical Program: The objective for
KSI-501 in DAYBREAK is to explore the efficacy potential of
bispecific VEGF and IL-6 inhibition in a broad treatment-naïve wet
AMD population. In preclinical models, KSI-501 was shown to be a
potent inhibitor of VEGF and IL-6 and, further, was shown to
normalize the blood retinal barrier opening the possibility that
KSI-501 may be a disease-modifying therapy for retinal vascular
diseases.
In the third quarter of 2024, we continued site activations and
patient enrollment for the Phase 3 DAYBREAK study in wet AMD.
DAYBREAK is a non-inferiority study including parallel
investigational arms of KSI-501 and tarcocimab against active
comparator aflibercept. Patients randomized to KSI-501 will receive
fixed every 8-week dosing with additional individualized dosing (up
to monthly dosing) on an as needed basis after four monthly loading
doses. Patients randomized to aflibercept will be dosed per its
label. Using the same treat-to-dryness approach as tarcocimab,
coupled with fixed intensive proactive dosing, maximizes both the
probability of meeting the primary endpoint as well as the
probability of demonstrating additional efficacy benefits.
DAYBREAK uses KSI-501's enhanced 50 mg/mL formulation containing
both conjugated and unconjugated antibody that is intended to
balance immediacy and durability.
- KSI-101 Clinical Program: We continued site
activation and patient enrollment in the third quarter of 2024 for
the Phase 1b APEX study of KSI-101.
KSI-101 is a novel, potent and high-strength (100 mg/mL)
bispecific protein targeting IL-6 and VEGF, which is a
"traditional" (unconjugated) intravitreal biologic. The APEX study
evaluates KSI-101 in two cohorts, Cohort 1 in patients with
diabetic macular edema ("DME") and Cohort 2 in patients with
macular edema secondary to inflammation ("MESI"). The goal of the
APEX study is to evaluate the safety and tolerability of KSI-101
and to identify two dose levels to progress into dual Phase
2b/3 studies (PEAK and PINNACLE) in
MESI.
- ABCD Platform™: We are expanding
our research pipeline of duets and triplets built from our modular
ABCD Platform that embeds diverse active pharmaceutical ingredients
("API") including small molecules, proteins, peptides, macrocycles,
and oligonucleotides in the biopolymer backbone to enable high drug
antibody ratio ("DAR") medicines with targeted, multi-specific,
tailored modulation of biological pathways for ophthalmic and
systemic diseases. We recently shared at the Investor R&D Day
that we are advancing two preclinical programs built on the ABCD
Platform.
One program is for the treatment of glaucoma, embedding in the
biopolymer backbone (i) an NLRP3 small molecule inhibitor, and (ii)
a second small molecule that lowers intraocular pressure ("IOP").
The NLRP3 inflammasome is an intracellular complex that drives
inflammation and cell death and is known to play a key role in
glaucoma progression. The goal of this program is to create an
intravitreally injected therapy that delivers two mechanisms of
action ("MOA") in a sustained release fashion, to fulfill the unmet
needs in the glaucoma field for non-topical, long-durability
therapy that delivers MOAs beyond IOP lowering.
The second program is for the treatment of dry AMD. Currently there
are no approved therapies for early or intermediate-stage dry AMD.
There are two approved therapies, both complement inhibitors, for
geographic atrophy ("GA"), the advanced stage of dry AMD. These
therapies require monthly or every other month intravitreal
injections and neither sufficiently halts disease progression. This
program at Kodiak explores the potential of embedding in the
biopolymer backbone (i) a macrocyclic peptide inhibitor of the
complement pathway, and (ii) an NLRP3 small molecule inhibitor. The
NLRP3 inflammasome is known to play a key role in AMD disease
etiology. The objective of this program is to create an
intravitreally injected ABCD platform-enabled therapy with a dual
mechanism of action to achieve better efficacy and extended
durability as compared to currently approved therapies for
GA.
Third Quarter 2024 Financial Results
Cash Position
Kodiak ended the third quarter of 2024 with $197.9 million of cash and cash equivalents. We
believe that our current cash will support our current and planned
operations into 2026.
Net Loss
The net loss for the third quarter of 2024 was $43.9 million, or $0.84 per share on both a basic and diluted
basis, as compared to a net loss of $50.0
million, or $0.95 per share on
both a basic and diluted basis, for the third quarter of 2023. The
net loss for the quarter ended September 30, 2024 included
non-cash stock-based compensation of $14.8
million, as compared to $13.9
million for the quarter ended September 30, 2023.
R&D Expenses
Research and development ("R&D") expenses were $31.9 million for the third quarter of 2024, as
compared to $36.2 million for the
third quarter of 2023. The R&D expenses for the third quarter
of 2024 included non-cash stock-based compensation of $6.3 million, as compared to $2.7 million for the third quarter of 2023. The
decrease in R&D expenses for the third quarter of 2024, as
compared to the same period in 2023, was primarily driven by
reduced manufacturing activities, decreased clinical activities for
completed trials, partially offset by costs from active clinical
trials for the tarcocimab development program as well as expanding
clinical activities for KSI-501 and KSI-101.
G&A Expenses
General and administrative ("G&A") expenses were
$14.8 million for the third quarter
of 2024, as compared to $18.3 million
for the third quarter of 2023. The G&A expenses for the third
quarter of 2024 included non-cash stock-based compensation of
$8.5 million, as compared to
$11.2 million for the third quarter
of 2023.
About tarcocimab tedromer (tarcocimab, KSI-301)
Tarcocimab is an investigational anti-VEGF therapy built on
Kodiak's proprietary Antibody Biopolymer Conjugate ("ABC") Platform
and is designed to maintain potent and effective drug levels in
ocular tissues for longer than existing available agents.
To date, tarcocimab has completed three successful Phase 3
pivotal clinical studies: the Phase 3 GLOW1 study in diabetic
retinopathy ("DR"), the Phase 3 BEACON study in retinal vein
occlusion ("RVO") and the Phase 3 DAYLIGHT study in wet AMD. In the
GLOW1 study, tarcocimab successfully treated DR patients and
prevented disease progression with 100% of patients on extended
6-month dosing. In the BEACON study, in the first 6 months
tarcocimab-treated patients were dosed on every 8-week interval (as
opposed to every 4-week interval for aflibercept) and in the second
6 months nearly half of tarcocimab patients did not require any
treatment while achieving similar vision and anatomical outcomes as
the aflibercept group at one year.
Tarcocimab is currently being studied in two Phase 3 clinical
trials, the GLOW2 study in diabetic retinopathy and the DAYBREAK
study in wet AMD.
The GLOW2 study has a similar design as GLOW1 in which all
patients randomized to investigational therapy will receive
tarcocimab on extended, 6-month dosing. GLOW2 features the benefit
of an additional, third monthly loading dose (baseline, Week 4,
Week 8) to explore even further benefits with tarcocimab in
diabetic retinopathy patients.
The DAYBREAK study includes tarcocimab in a second
investigational arm against active comparator aflibercept and
incorporates learnings from prior pivotal trials of tarcocimab to
maximize the probability of meeting the primary endpoint of
non-inferiority in visual acuity gains. Patients randomized to
tarcocimab will receive individualized dosing every 4 to 24 weeks
on an as needed basis following four monthly loading doses.
Patients randomized to aflibercept will be dosed per its label. The
individualized dosing of tarcocimab is determined by a
treat-to-dryness proactive approach, using presence of retinal
fluid as a disease activity marker, instead of a combination of
central subfield thickness ("CST") and vision loss, which resembles
retina specialists' practice and optimizes each patient's
treatment. The objectives for tarcocimab in DAYBREAK are to assess
its 6-month durability potential, strengthen its competitive
position in wet AMD and bolster the regulatory application package
for the program.
Both GLOW2 and DAYBREAK use tarcocimab's enhanced 50 mg/mL
formulation containing both conjugated and unconjugated antibody
that is intended to balance immediacy and durability. GLOW2 and
DAYBREAK are both actively enrolling patients. Additional
information about GLOW2 can be found on
www.clinicaltrials.gov under Trial Identifier NCT06270836
(https://clinicaltrials.gov/study/NCT06270836). Additional
information about DAYBREAK can be found on
www.clinicaltrials.gov under Trial Identifier NCT06556368
(https://clinicaltrials.gov/study/NCT06556368).
About KSI-501
KSI-501 is an anti-IL-6, VEGF-trap bispecific antibody
biopolymer conjugate built on the ABC platform and is being
developed for high prevalence retinal vascular diseases to address
the leading unmet needs of extended durability and targeting
disease biology beyond VEGF for differentiated efficacy. In
preclinical models, KSI-501 was shown to be a potent inhibitor of
VEGF and IL-6 and, further, was shown to normalize the blood
retinal barrier, opening up the possibility that KSI-501 may be a
disease-modifying therapy for retinal vascular diseases.
Furthermore, higher intraocular levels of IL-6 are correlated with
poorer BCVA outcomes over time in wet AMD patients treated with
anti-VEGF monotherapy, which suggests that IL-6 inhibition in
combination with anti-VEGF therapy could lead to improved
outcomes.
A completed Phase 1 multiple ascending dose study demonstrated
that repeated monthly dosing of KSI-501 was safe and well tolerated
and achieved clinically meaningful and sustained improvement in
visual acuity and fluid reduction in patients with diabetic macular
edema.
Kodiak has advanced KSI-501 into a Phase 3 study DAYBREAK to
evaluate its efficacy and safety in wet AMD. The DAYBREAK study is
a non-inferiority study evaluating parallel investigational arms of
KSI-501 and tarcocimab against active comparator aflibercept.
Patients randomized to KSI-501 will receive fixed every 8-week
dosing with additional individualized dosing (up to monthly dosing)
on an as needed basis after 4 monthly loading doses. Patients
randomized to aflibercept will be dosed per its label. The primary
endpoint is non-inferiority in change in visual acuity from
baseline to the average of Week 40, 44 and 48. DAYBREAK uses
KSI-501's enhanced 50 mg/mL formulation containing both conjugated
and unconjugated antibody that is intended to balance immediacy and
durability. The objective for KSI-501 in DAYBREAK is to explore the
efficacy potential of bispecific VEGF and IL-6 inhibition in a
broad treatment-naïve wet AMD population. DAYBREAK is now actively
enrolling patients. Additional information about DAYBREAK can be
found on www.clinicaltrials.gov under Trial Identifier
NCT06556368 (https://clinicaltrials.gov/study/NCT06556368).
About KSI-101
KSI-101 is a novel, potent and high strength (100 mg/mL)
bispecific protein targeting IL-6 and VEGF. We are developing
KSI-101 for patients who have retinal fluid and inflammation.
Currently there are no available intravitreal biologic therapies
addressing the spectrum of inflammatory conditions of the retina.
We believe that retinal inflammatory conditions represent a new
market segment separate from the established anti-VEGF market.
KSI-101 is a clinical prospect with opportunities and risks
uncoupled from the ABC Platform, and as such is an important part
of our portfolio. We have initiated a dose-finding Phase
1b study APEX. The APEX study
evaluates KSI-101 in two cohorts, Cohort 1 in patients with
diabetic macular edema ("DME") and Cohort 2 in patients with
macular edema secondary to inflammation ("MESI"). The goal of the
APEX study is to evaluate the safety and tolerability of KSI-101
and to identify two dose levels to progress into dual Phase
2b/3 studies (PEAK and PINNACLE) in
MESI. APEX study is now actively enrolling patients.
About Kodiak Sciences Inc.
Kodiak Sciences (Nasdaq: KOD) is a biopharmaceutical company
committed to researching, developing, and commercializing
transformative therapeutics to treat a broad spectrum of retinal
diseases. We are focused on bringing new science to the design and
manufacture of next generation retinal medicines to prevent and
treat the leading causes of blindness globally. Our ABC Platform™
uses molecular engineering to merge the fields of protein-based and
chemistry-based therapies and has been at the core of Kodiak's
discovery engine. We are developing a portfolio of three clinical
programs, two of which are late-stage today and derived from our
ABC Platform and one which is platform-independent and which we
believe can progress rapidly into pivotal studies.
Kodiak's lead investigational medicine, tarcocimab, is a novel
anti-VEGF antibody biopolymer conjugate under development for the
treatment of high prevalence retinal vascular diseases. Tarcocimab
is currently being studied in two Phase 3 clinical trials, GLOW2 in
patients with diabetic retinopathy and DAYBREAK in patients with
wet AMD. Both studies are actively enrolling patients.
KSI-501 is our second investigational medicine, a first-in-class
anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate
designed to inhibit both IL-6 mediated inflammation and
VEGF-mediated angiogenesis and vascular permeability. KSI-501 is
being developed for the treatment of high prevalence retinal
vascular diseases to address the unmet needs of extended durability
and targeting disease biology beyond VEGF for differentiated
efficacy. The Phase 3 DAYBREAK study of KSI-501 in wet AMD is
actively enrolling patients.
KSI-101, our third product candidate, is a novel anti-IL-6,
VEGF-trap bispecific protein. Kodiak is developing KSI-101 for the
treatment of retinal inflammatory diseases, as currently there are
no available intravitreal biologic therapies addressing the
spectrum of inflammatory conditions of the retina. The Phase
1b APEX study of KSI-101 is actively
enrolling patients, as a precursor to activating the Phase
2b/3 PEAK and PINNACLE studies in
patients with macular edema secondary to inflammation
("MESI").
Kodiak is advancing its platform technology to embed small
molecules and other active pharmaceutical ingredients ("APIs") into
Kodiak's proprietary biopolymer backbone to enable high
drug-antibody-ratio ("DAR") medicines. The diverse APIs are
designed to be released over time to achieve targeted,
multi-specific and tailored modulation of biological pathways. The
unique combination of high DAR and tailored therapeutic benefit
offers potential for broad application to multifactorial diseases
and builds directly from our Antibody Biopolymer Conjugate
technology and its 15 years of design, development and
manufacturing experience. We call this platform extension our
Antibody Biopolymer Conjugate Drug ("ABCD") Platform because we are
extending our platform capabilities to include the conjugation of
small molecule drugs whereas historically we primarily conjugated
biologics such as antibodies.
For more information, please visit www.kodiak.com.
Kodiak®, Kodiak Sciences®, ABC ™, ABC Platform™, ABCD™ and the
Kodiak logo are registered trademarks or trademarks of Kodiak
Sciences Inc. in various global jurisdictions.
Forward-Looking Statements
This release contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
not based on historical fact and include statements regarding: the
potential for DAYBREAK to support marketing authorization
applications for tarcocimab and KSI-501; Kodiak's increasing
commercial-facing manufacturing activities; Kodiak's increasing
BLA-facing clinical activities, including the plan to file a single
BLA for three diseases with data from five successful Phase 3
studies with tarcocimab; the maturation of our biopolymer derived
triplets platform; the potential for GLOW2 to serve as one of the
two successful pivotal studies in diabetic retinopathy to support a
marketing authorization application for tarcocimab; the prospects
and potential benefits of the product candidates in our pipeline,
including tarcocimab, KSI-501, and KSI-101; the timing of
activation and completion of our planned and ongoing studies,
including the activation of the twin PEAK and PINNACLE pivotal
studies; the potential success of our ongoing studies; and our
guidance on our cash runway. Forward-looking statements generally
include statements that are predictive in nature and depend upon or
refer to future events or conditions, and include words such as
"may," "will," "should," "would," "could," "expect," "plan,"
"believe," "intend," "pursue," and other similar expressions among
others. Any forward-looking statements are based on management's
current expectations of future events and are subject to a number
of risks and uncertainties that could cause actual results to
differ materially and adversely from those set forth in or implied
by such forward-looking statements. The risks and uncertainties
include, but are not limited to: the risk that cessation or delay
of any of the on-going clinical studies and our development of
tarcocimab, KSI-501 or KSI-101 may occur; the risk the results of
our ongoing studies may not provide the evidence, insights, or
benefits as anticipated; the risk that safety, efficacy, and
durability data observed in our product candidates in current or
prior studies may not continue or persist; the risk that the
results of the tarcocimab Phase 3 studies may not be sufficient to
support a single BLA submission for wet AMD, RVO and NPDR; the risk
that a BLA may not be accepted by, or receive approval from, the
FDA or foreign regulatory agencies when expected, or at all; future
potential regulatory milestones of tarcocimab, KSI-501 or KSI-101,
including those related to current and planned clinical studies,
may be insufficient to support regulatory submissions or approval;
the risk that a new formulation of tarcocimab, KSI-501 or other ABC
Platform or ABCD Platform derived molecules may not provide the
benefits expected; our research and development efforts and our
ability to advance our product candidates into later stages of
development may fail; the risk that KSI-501 may not inhibit VEGF
and IL-6 or have an impact on the treatment of patients as
expected; any one or more of our product candidates may not be
successfully developed, approved or commercialized; our
manufacturing facilities may not operate as expected; adverse
conditions in the general domestic and global economic markets,
which may significantly impact our business and operations,
including our clinical trial sites, as well as the business or
operations of our manufacturers, contract research organizations or
other third parties with whom we conduct business; as well as the
other risks Identified in our filings with the Securities and
Exchange Commission. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause our actual results to differ from those contained in the
forward-looking statements, see the section entitled "Risk Factors"
in our most recent Form 10-K, as well as discussions of potential
risks, uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date hereof and
Kodiak undertakes no obligation to update forward-looking
statements, and readers are cautioned not to place undue reliance
on such forward-looking statements. Kodiak®, Kodiak Sciences®,
ABC™, ABC Platform™, ABCD™ and the Kodiak logo are registered
trademarks or trademarks of Kodiak Sciences Inc. in various global
jurisdictions.
Kodiak Sciences
Inc.
Condensed
Consolidated Statements of Operations
(in thousands,
except share and per share amounts)
(Unaudited)
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
|
Nine Months
Ended
September 30,
|
|
|
|
2024
|
|
|
2023
|
|
|
2024
|
|
|
2023
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
31,878
|
|
|
$
|
36,188
|
|
|
$
|
94,323
|
|
|
$
|
159,669
|
|
General and
administrative
|
|
|
14,754
|
|
|
|
18,312
|
|
|
|
46,347
|
|
|
|
54,278
|
|
Total operating
expenses
|
|
|
46,632
|
|
|
|
54,500
|
|
|
|
140,670
|
|
|
|
213,947
|
|
Loss from
operations
|
|
|
(46,632)
|
|
|
|
(54,500)
|
|
|
|
(140,670)
|
|
|
|
(213,947)
|
|
Interest
income
|
|
|
2,711
|
|
|
|
4,536
|
|
|
|
9,018
|
|
|
|
12,836
|
|
Interest
expense
|
|
|
—
|
|
|
|
(5)
|
|
|
|
—
|
|
|
|
(13)
|
|
Other income
(expense), net
|
|
|
(25)
|
|
|
|
(38)
|
|
|
|
(450)
|
|
|
|
149
|
|
Net loss
|
|
$
|
(43,946)
|
|
|
$
|
(50,007)
|
|
|
$
|
(132,102)
|
|
|
$
|
(200,975)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.84)
|
|
|
$
|
(0.95)
|
|
|
$
|
(2.51)
|
|
|
$
|
(3.84)
|
|
Weighted-average shares
of common stock
outstanding used in computing net loss
per
common share, basic and diluted
|
|
|
52,616,183
|
|
|
|
52,455,620
|
|
|
|
52,560,489
|
|
|
|
52,391,083
|
|
Kodiak Sciences
Inc.
Condensed
Consolidated Balance Sheet Data
(in
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
September 30,
2024
|
|
|
December 31,
2023
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
|
197,864
|
|
|
$
|
285,507
|
|
Working
capital
|
|
|
|
|
|
$
|
178,433
|
|
|
$
|
247,580
|
|
Total assets
|
|
|
|
|
|
$
|
372,669
|
|
|
$
|
479,372
|
|
Accumulated
deficit
|
|
|
|
|
|
$
|
(1,284,633)
|
|
|
$
|
(1,152,531)
|
|
Total stockholders'
equity
|
|
|
|
|
|
$
|
185,370
|
|
|
$
|
265,781
|
|
View original
content:https://www.prnewswire.com/news-releases/kodiak-sciences-announces-recent-business-highlights-and-third-quarter-2024-financial-results-302306357.html
SOURCE Kodiak Sciences Inc.